|Recognition List Number: 026 FR Publication Date: 03/18/2011
Part B: Supplementary Information
Recognition Number 1-84: ISO 5366-3:2001, anaesthetic and respiratory equipment -- tracheostomy tubes -- part 3: pediatric tracheostomy tubes technical corrigendum 1. (Anesthesias)
Date of Standard: 2003.
|Address of Standards Development Organization:|
| International Organization for Standardization (ISO)*|
| 1, Rue de Varembe|
| Case Postale 56|
| CH 1211 Geneva 20, 0 |
|CDRH Offices and Divisions associated with recognized standards:|
|(1)||OFFICE OF COMPLIANCE (OC) |
|(2)||OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB) |
|DIVISION OF POSTMARKET SURVEILLANCE (DPS) |
|(3)||OFFICE OF DEVICE EVALUATION (ODE) |
|Tracheostomy Tubes Made of Elastomeric and/or Rubber Materials and Connectors|
|Processes Affected: |
|All Pediatric Tracheostomy Tubes|
|Type of Standard:|
| Vertical, International|
|Extent of Recognition:|
|Complete 2003 Technical Corrigendum 1
Additional Note: for conformance with ISO 5366-3:2001; refer to standard recognition number 1-36 which refers its extent of recognition as follows:
Clause 6.1. Information related to the resistance to cleaning, disinfection, and sterilization agents should be provided, including a description of test methods, acceptance criteria, and results. For those devices that use ethylene oxide as a sterilant, the residue levels of ethylene oxide, ethylene chlorohydrin, and ethylene glycol shall not exceed 250 ppm, 250 ppm, and 5000 ppm, respectively.
Clause 4.3. is recognized with clarification. Because the device is considered to have permanent-duration contact with tissue and mucosal membrane, the device is considered external communicating, and reports of cytotoxicity, sensitization, genotoxicity, and implantation testing should be provided as indicated in ISO 10993-1. All biocompatibility test should be performed after the device has been sterilized initially (for products provided sterile) or after recommended sterilization procedure.
Clause 4.6. is not recognized. ASTM F 1242-96, Section 5.1 applies.
Clause 7.1 is not recognized. 21 CFR 801.15(c)(1) states that all words, statements, and other information required by the Act to appear on the label or labeling shall appear in the English language. English labeling allows immediate and positive verification for the proper use of medical equipment. As outlined in 21 CFR 807.87(e), proposed labels and labeling shall be sufficient to describe the directions for use of the device, and Section 502(f) of the Act requires adequate directions for use. All device labeling should contain English text adjacent to any icons/symbols used if space permits. If space does not permit, the icon/symbols should be replaced with English text only.
Clause 126.96.36.199b is recognized in part. Markings on trachel tubes which indicates inner or outer diameter should be accompanied by text or letters identifying the numbers as diameters.
ASTM F 1242-96, Section 5.1 and A1.3 (cuff symmetry test) and ASTM F 1242-96, Section 5.3 and A1.7 (leak test) also apply.
Annex D.1.1 Information related to the tube rigidity characteristics shall be provided, including a description of the test methods and results.
|Related CFR Citations and Product Codes:|
||Tube Tracheostomy And Tube Cuff
||Tube, Tracheostomy (W/Wo Connector)
|Relevant Guidance: |
|Reviewer Guidance for labeling reusable medical devices for reprocessing in health care facilities, April 1996|
|FDA Technical Contact:|
| Tam Cillie |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2536 |
| Silver Spring MD 20993 |
| 301/796-6269 |
| email: email@example.com|
|* in the United States, copies of this standard can be obtained from:|
| American National Standards Institute (ANSI)*|
| 25 West 43rd Street|
| 4th Floor|
| New York, NY 10036 |